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A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer Clinical research trials and A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer. A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer
A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer
For Condition: Carcinoma, Renal Cell
Status: Recruiting
Sponsor(s): Bayer Corporation , ONYX Pharmaceuticals
Synopsis: To evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY 43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regiment for advanced disease.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented. - Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization. - Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) - Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 - Patients who have adequate coagulation, liver and kidney functions. Exclusion Criteria: - Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors. - Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignacies curatively treated > 2 years prior to entry. - Cardiac arrhythmias requiring anti-arrhythmics, symptomtic coronary artery disease or ischemia or congestive heart failure. - Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. - Patients with a history or presence of metastatic brain or metastatic brain or meningeal tumors. - Patients with seizure disorder requiring medication (such as anti-epileptics). - History of organ alograft or bone marrow transplant of stem cell rescue. - Patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control. - Patients who have three or more of the following: 1. ECOG performance status greater than or equal to 2 2. Abnormally high lactate dehydrogenase 3. Abnormally high serum hemoglobin 4. Abnormally high corrected serum calcium 5. Absence of prior nephrectomy Excluded therapies and medications, previous and concomitant: - Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphanats - Significant surgery with 4 weeks of start of study - Investigational drug therapy during or within 30 days - Concomitant treatment with rifampin or St. John's Wort - Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors - Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors.
Total Enrollment: 800
Location and Contact Information:
Overall Study Official:
RonaldBukowski, Principal Investigator, Cleveland Clinic Cancer Center, Cleveland, Ohio, USA
Palmetto Hematology Oncology, P.A., Gibbs cancer Center *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bradof 864-560-1841
Vivantes Klinikum Am Urban *Recruiting*
Berlin, , 10967
Germany
Recruiting Michael Siegsmund 49-30-697-0
Frederick Memorial Hospital *Recruiting*
Frederick, Maryland, 21701
United States
Recruiting Paul Rausch 301-662-8477
Centre Rene Gauducheau *Recruiting*
Saint-Herblain, , 44805
France
Recruiting Frederic Rolland 33-2-40-67-99-76
Policlinico Universitario S. Matteo *Recruiting*
Pavia, , 27100
Italy
Recruiting Camillo Porta 39-0382-502161
Universitats-Krankenhaus Eppendorf *Recruiting*
Hamburg, , 20251
Germany
Recruiting Hans Heinzer 49-40-42803-3442
Instituto Valendiano de Oncologia *Recruiting*
Valencia, , 46009
Spain
Recruiting Miguel Climent 34-96-111-40-52
The Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Ronald Bukowski 216-444-6825
City Oncology Hospital *Recruiting*
Kiev, , 115
Ukraine
Recruiting Ivan Klimenko 38-044-450-74-80
Krankenhaus Nordwest *Recruiting*
Frankfurt, Hessen, 60488
Germany
Recruiting Elke Jager 49-69-7601-3380
Klinikm der Universitat Regensburg *Recruiting*
Regensburg, Bayern, 93053
Germany
Recruiting Stefan Krause 49-941-944-5538 5
Lvov Cancer Center *Recruiting*
Lvov, , 79031
Ukraine
Recruiting Yaroslav Shparik 380-0322-23-09-72
Pretoria Urology Hospital *Recruiting*
Pretoria, Gauteng,
South Africa
Recruiting Lance Coetzee 27-12-342-9432
Altay Oncological Dispensary *Recruiting*
Kazan, , 420029
Russian Federation
Recruiting Vladimir Lubennikov 7-3852-23-26-20
Grigoriev Institute *Recruiting*
Kharkiv, , 61024
Ukraine
Recruiting Pilipenko Nikolay 38-057-431-542
Wojewodzka Przychodnia Onkolog *Recruiting*
Gdansk, , 80-210
Poland
Recruiting Ewa Solska 48-58-341-70-45
Institut Gustave Roussy (IGR), 39 rue Camille Desmoulins *Recruiting*
Villejuif, , 94805
France
Recruiting Bernard Escudier (33) 1 42 11 54 10
Canberra Hospital *Recruiting*
Woden, , ACT 2606
Australia
Recruiting David Leong 61-2-6244-3856
Oddzial Chorob Rozorstowych *Recruiting*
Lodz, , 93-509
Poland
Recruiting Maria Blasinska-Morawiec 48-42-689-54-71
Hospital Europeen Georges Pompidou *Recruiting*
Paris, , 75908
France
Recruiting Stephane Oudard 33-1-56-09-34-76
Medical Department, Christie Hospital *Recruiting*
Manchester, , M20 4B
United Kingdom
Recruiting Robert Hawkins 44-161-446-8338
Jewish General Hospital *Recruiting*
Quebec City, Quebec, H3T 1E2
Canada
Recruiting Wilson Miller 514-340-8222
Klinika Urologi, Pomorksa Akademia Medyczna *Recruiting*
Szczecin, , 70-111
Poland
Recruiting Andrzej Sikorski 48-91-466-11-00
Klinika Chemioterapii *Recruiting*
Krakow, , 31-115
Poland
Recruiting Marek Pawlicki 48-12-423-10-34
Klinika Onkologie, Centralny Szpital Kliniczny *Recruiting*
Warszawa, , 00-909
Poland
Recruiting Cezary Szczylik 48-22-610-30-98
Mary Potter Oncology Resarch *Recruiting*
Pretoria, Gauteng, 0001
South Africa
Recruiting Graham Cohen 27-12-346-6701
Instituto Regina Elena *Recruiting*
Roma, , 00144
Italy
Recruiting Francesco Cognetti 39-06-5-266-6228
Klinikum Grosshadern der Ludwig-Maximilians-Universitat *Recruiting*
Munchen, , 81377
Germany
Recruiting Michael Siebels 49-89-7095-0
Klinikum der Justus-Liebig-Universitat *Recruiting*
Giessen, , 35392
Germany
Recruiting W Weidner
Dept. of Oncology *Recruiting*
Budapest, , 1032
Hungary
Recruiting Marta Baki 36-1-250-2420/292
Dept of Urology, Tygerberg Hospital *Recruiting*
Cape Town, , 7500
South Africa
Recruiting C Heyns 27-21-938-9282
Ichilov Hospital *Recruiting*
Tel Aviv, , 64239
Israel
Recruiting R Ben-Yoself 972-2-697-4444
Louisiana Oncology Associates *Recruiting*
Lafayette, Louisiana, 70506
United States
Recruiting David Rinaldi 337-235-7898
Azienda Ospedali Riuniti *Recruiting*
Bergamo, , 24128
Italy
Recruiting Roberto Labianca 39-035-269-724
Institut Paoli-Calmettes *Recruiting*
Marseille, , 13273
France
Recruiting Gwenaelle Gravis 33-4-91-22-33-33
Northern Centre for Cancer Treatment *Recruiting*
Newcastle upon Tyne, , NE4 5BE
United Kingdom
Recruiting Rhona McMenemin 01-91-2194299
Hematology/Oncology of Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-832-1093
Optima Research *Recruiting*
Laredo, Texas, 78041
United States
Recruiting Yadvindera Bains 956-753-2229
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Scott North 780-432-8762
Centre Oscar Lambret *Recruiting*
Lille Cedex, , 59020
France
Recruiting Armelle Caty 33-3-20-29-59-42
University of Chicago Medical Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Apurva Desai 773-702-6149
Katedra Onkologi *Recruiting*
Lublin, , 20-090
Poland
Recruiting Maria Mazurkiewicz 48-81-747-75-11
Ludwiz Institute Oncology Unit *Recruiting*
Heidelberg, , VIC 3084
Australia
Recruiting Ian Davis 61-3-9496-5000
Rambam Oncology Institute *Recruiting*
Haifa, , 31096
Israel
Recruiting Elli Gez 972-3-854-3812
Columbia Presbyterian Medical Center *Recruiting*
New York City, New York, 10032
United States
Recruiting Daniel Petrylak 212-305-1731
Katedra i Klinka Urologi AM *Recruiting*
Wroclaw, , 50-043
Poland
Recruiting Jerzy Lorenz 48-71-343-47-59
Universidad de Chile Hospital *Recruiting*
Santiago de Chile, ,
Chile
Recruiting Miguel Fodor 56 2 6788974
Dept of Radiotherapy & Oncology, Addington Hospital *Recruiting*
Durban, Kwazulu Natal, 4001
South Africa
Recruiting J Jordaan 27-31-327-2182
Jefferson Oncology Group *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Gaetano Cardi 215-955-8875
East Valley Heamtology Oncology Medical Group *Recruiting*
Burbank, California, 91505
United States
Recruiting Raul Mena 213-989-1888
Virginia Physicians Inc. *Recruiting*
Richmond, Virginia, 23294
United States
Recruiting Gregory Formanek 804-346-1702
Pacific Shores Medical Group *Recruiting*
Long Beach, California, 90813
United States
Recruiting Nerses Tchekmedyian 562-590-0345
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Joel Picus 314-747-1367
Institut Claudius Regaud *Recruiting*
Toulouse, , 31052
France
Recruiting Christine Chevreau 33-5-61-42-41-74
Dept. of Chemotherapy C and Clinical Pharmacology *Recruiting*
Budapest, , 1121
Hungary
Recruiting Istvan Bodrogi 36-1-224-8600
Border Medical Oncology *Recruiting*
Wodonga, , 3690
Australia
Recruiting Christopher Steer 02-6055-3200
Dienst Oncologie *Recruiting*
Brussels, , 1090
Belgium
Recruiting Jacques Greve 32-2-477-60-40
Kentuckiana Cancer Institute, PLLC *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting Alfonso Cervera 502-561-8200
Ellis Fischel Cancer Center *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Clay Anderson 573-882-6964
Hospital Vall d'Hebron *Recruiting*
Barcelona, , 08035
Spain
Recruiting Joaquim Bellmunt 34-93-2746000
Velindre Hospital *Recruiting*
Cardiff, South Glamorgan,
United Kingdom
Recruiting Philip Savage 44-29-206145888
Johannesburg Academic Hospital, Oncology Dept *Recruiting*
Johannesburg, , 2193
South Africa
Recruiting Paul Ruff 27-11-488-4452
Hemoncare, PC *Recruiting*
Brooklyn, New York, 11235
United States
Recruiting Fakhiuddin Ahmed 718-616-0801
Klinika Onkologie, Oddzial Chemioterapii *Recruiting*
Poznan, , 61-878
Poland
Recruiting Piotr Tomczak 48-61-854-90-38
Liverpool Hospital *Recruiting*
Liverpool, , NSW1871
Australia
Recruiting Elizabeth Hovey 02--9828-5180
Centrum Onkologii *Recruiting*
Warszawa, , 02-781
Poland
Recruiting Tomasz Demkow 48-22-546-27-22
Dept Medical Oncology, Westmead Hospital *Recruiting*
Westmead, , NSW 2145
Australia
Recruiting Howard Gurney 02-9845-8988
Urology Clinic *Recruiting*
Debrecen, , 4004
Hungary
Recruiting Csaba Toth 36-52-413-279
Centre Leon Berard *Recruiting*
Lyon, , 69008
France
Recruiting Sylvie Negrier 33-4-78-78-2751
Klinikum Mannheim *Recruiting*
Mannheim, Wurttemberg, 68167
Germany
Recruiting Maurice-Stefan Michel 49-621-383-3584
Texas Oncology,P.A. *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Thomas Hutson 214-370-1780
Ospedale Civile S.Maria Nuova *Recruiting*
Reggio Emilia, , 42100
Italy
Recruiting Corrado Boni 39-0522-296858
Donetsk Regional Oncological C *Recruiting*
Donetsk, , 83092
Ukraine
Recruiting Yury Dumansky 38-0622-22-58-09
Servicio de Oncologia, Hospital Clinico San Carlos *Recruiting*
Madrid, , 28040
Spain
Recruiting Jose Gonzalez 34-913303000
University of Colorado Urologic Oncology Clinic *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Harry Drabkin 720-848-0170
ACRC/Arizona Clinical Research Center *Recruiting*
Tucson, Arizona, 85712
United States
Recruiting Donald Brooks 520-290-2510
New Grootte Schuur Hospital *Recruiting*
Cape Town, Western Cape,
South Africa
Recruiting R Abratt 27-21-404-4266
Regional Cancer Dispensary *Recruiting*
Poltava, , 36024
Ukraine
Recruiting Vladimir Bashtan 38-0532-50-28-22
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting David McDermott 617-667-1931
Instituto dei Tumori *Recruiting*
Milano, , 20133
Italy
Recruiting Emilio Bajetta 39-02-23902500
Hamilton Regional Cancer Center *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Sebastien Hotte 905-387-9495
OCI/Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Malcolm Moore 416-946-4501
City Clinical Oncology Dispens *Recruiting*
St Petersburg, , 197758
Russian Federation
Recruiting Pyotr Karlov 7-812-376-89-20
RPAH Level 6,Gloucester House *Recruiting*
Camperdown, , NSW 2050
Australia
Recruiting Michael Boyer 02-0915-7695
Centre Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Emmanuel Sevin
Dept of Urology, University of the Free State *Recruiting*
Bloemfontein, Free State, 9300
South Africa
Recruiting S Wentzel 27-51-405-3792
Groupe Hospitalier Saint Andre-Jean Abadie *Recruiting*
Bordeaux, , 33075
France
Recruiting Alain Ravaud 33-05-56-79-58-08
Dept. of Oncology *Recruiting*
Szekesfehervar, , 8000
Hungary
Recruiting Jozsef Cseh 36-22-535-662
Our Lady of Mercy Medical Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Janice Dutcher 718-920-9057
University of Utah Health Sciences Center *Recruiting*
Salt Lake City, Utah, 84132
United States
Recruiting Richard Middleton 801-581-3739
Additional Information:
Study ID Numbers: 11213.IND 60,453/SN 317. CDER;
Study Start Date: October 2003
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073307
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A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer
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